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Study of the Platelet Function During the Last Month of Pregnancy

Study of the Platelet Function During the Last Month of Pregnancy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02828852
Acronym
VPI
Enrollment
60
Registered
2016-07-12
Start date
2010-05-01
Completion date
2016-07-01
Last updated
2026-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

pregnancy, platelets

Brief summary

The objective is to compare women's platelet answer in the last month of pregnancy to women old enough to procreate, no pregnancy and without hormonal treatment. The hypothesis of research is that the decrease of platelet answer in pregnant women could not only limit the occurence of embolic accidents but also explain the lowest incidence of the arterial thrombosis in comparison with the venous thrombosis.

Detailed description

This is a monocentric study comparing a group of pregnant women and a group of "no pregnancy" women. The goal of the present study is to determine the impact of pregnancy on platelet function. For this, the study propose to explore, in women in the last month of pregnancy, the ability of platelets to aggregate after activation by strong agonists but also their ability to adhere to a matrix and form thrombies. The study will include 30 pregnant and 30 "no pregnancy" control women, of childbearing age and not taking hormone therapy. From a blood sample, two types of examination will be implemented: A) In whole blood, we will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed. B) In washed platelets and whole blood, we shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.

Interventions

OTHERBlood sample

In washed platelets and whole blood, study shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made. In whole blood, study will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Signature of the form of consent * Absence of any physical or psychic pathology which can interfere with the normal realization of the study * Group1 : Women in the last month of pregnancy * Group 2 : Women old enough to procreate, no pregnancy and without hormonal treatment

Exclusion criteria

* Thrombopenia (platelet numeration \< 120 000 / mm3), * Gestational diabet, * Hormonal treatment : oestrogen-progestagen, progestagen, Selective Estrogen Receptor Modulator (SERM), inductors of ovulation, * Anticoagulant and any medication which can intervene on the platelet function (AINS, antidepressants) * Personal history of thromboembolic accident venous or arterial, * Personal history of haemostasis disease * Personal history of hepatic or renal disease * Personal history of autoimmune disease.

Design outcomes

Primary

MeasureTime frameDescription
surface covered by plateletsbaselinePercentage of surface covered by platelets (using the software Metamorph)
Volume of thrombiesbaselineTotal volume of thrombies in μm3 (using the software Metamorph)

Secondary

MeasureTime frameDescription
Platelet aggregationbaselinePercentage of platelet aggregation (whole blood and washed platelets)
chemokine Platelet Factor 4baselineQuantity of the chemokine Platelet Factor 4 (PF4) (IU/ml) secreted by the granules after activation by these agonists (washed platelets)
ThromboglobulinbaselineQuantity of thromboglobulin (in ng / ml) secreted by the granules after activation by these agonists (washed platelets)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPARANT Olivier, MD PhD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026